Biomedical subjects
Publications and source records attributed to K Linde.
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The frequency of use of traditional Chinese drugs was investigated in relation to Western and Chinese diagnostic classifications in a hospital for traditional Chinese medicine in Germany. All 1597 in-patients treated in the hospital between February 1992 and August 1993 entered a prospective observational study. About two thirds of the patients suffered from chronic pain syndromes, the most frequent single diagnosis being migraine (n=244). All patients were treated with at least one of four Chinese therapies (traditional Chinese drugs, acupuncture, Tuina-massage, Qi-gong). 95.1% of all patients received traditional Chinese drug treatment, prescribed in complex prescriptions including 3 to 12 single drugs from a total of 305. Drug patterns prescribed to patients with the same Western diagnosis tended to be similar, but could differ strongly for single drugs in subgroups with distinct Chinese diagnoses. Studies evaluating traditional Chinese treatment strategies in patients classified according to Western nosology should take into account possible diagnostic differences according to Chinese nosology. The development of a reliable coding system for Chinese diagnostic classifications is a precondition for further cross-cultural studies.
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We investigated the influence of indicators of methodological quality on study outcome in a set of 89 placebo-controlled clinical trials of homoeopathy in three different ways: (1) The results of studies meeting single criteria (explicit statement of random allocation, allocation concealment, double-blinding, completeness of follow-up) of methodological quality were compared with those of studies not meeting the criteria in univariate and multivariate analyses; (2) The results of studies scoring above and below predefined scores in two quality assessment scales were compared; (3) Primary studies were consecutively entered into a cumulative meta-analysis according to the summary scores derived from the quality assessment scales. All analyses were performed using meta-regression methods. Studies that were explicitly randomized and were double-blind as well as studies scoring above the cut-points yielded significantly less positive results than studies not meeting the criteria. In the cumulative meta-analyses, there was a trend for increasing effect sizes when more studies with lower-quality scores were added. However, there was no linear relationship between quality scores and study outcome. We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results. Because summarizing disparate study features into a single score is problematic, meta-regression methods simultaneously investigating the influence of single study features seem the best method for investigating the impact of study quality on outcome.
BACKGROUND: Use of traditional Chinese drug treatment is widespread. While cases of hepatotoxic effects have been reported, little is known about the frequency of such effects. OBJECTIVES: To investigate the frequency, magnitude and course of liver enzyme elevations in patients treated with traditional Chinese drugs. DESIGN: Retrospective study. SETTING: Hospital for traditional Chinese medicine in Germany. PATIENTS: All 1507 patients admitted for inpatient treatment between February 1994 and July 1995. MAIN OUTCOME MEASURE: Number of patients who presented at discharge with a more than 2-fold elevation of alanine amino transferase (ALT) levels (over maximum normal values or elevated admission values). RESULTS: A more than 2-fold elevation of ALT values was observed in 14 patients (0.9%). In 13 cases a causal relationship with Chinese drug therapy seemed possible and, for one patient, likely. However, all patients were also on non-Chinese drug treatment. Follow-up values of ALT within 8 weeks after discharge were normal in 11 patients (six of them had continued to take traditional Chinese drugs) and close to normal in the remaining three. In five patients there were indications for previous liver damage. CONCLUSIONS: In the population and setting studied, clinically relevant liver enzyme elevations occurred in about 1/100 patients treated with traditional Chinese drugs.
OBJECTIVE: To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. DESIGN: Systematic review. STUDY SELECTION: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. DATA SOURCES: Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. RESULTS: Twenty-two trials, including a total of 1042 patients (median 36, range 10-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. CONCLUSIONS: Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions.
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In each of two experiments, the effects of inoculation of Listeria monocytogenes into the ovine mammary gland were studied. In the first experiment, ewes were challenged with one or other of five different Listeria spp. isolates to study differences in their pathogenicity. In the second, ewes were challenged with L. monocytogenes serotype 1/2a to study the sequential features of the infection. The reaction of the mammary glands was assessed by bacteriological, cytological and histological methods. No distinct variation in the pathogenicity of L. monocytogenes isolates was evident: all produced subclinical mastitis, independently of their origin or serotype; a L. innocua isolate caused only a transient increase of milk somatic cell counts. After challenge, L. monocytogenes was isolated for 88 days from the milk of inoculated glands, whose milk somatic cell counts were greater than 1.0 x 10(6) cells ml-1. The organism was also isolated from the mammary lymph nodes, but not from any internal organ of any inoculated ewe. In early stages of the infection neutrophilic infiltration was the predominant histological feature, but hyperaemia, and degeneration of alveolar epithelial cells were also recorded. Later, chronic inflammatory features predominated, with lymphocytes as the principal cell types, destruction of alveoli and fibrous tissue proliferation. In the final stage of the experiment, fibrosis was the salient finding. It is concluded that L. monocytogenes can cause subclinical mastitis after intramammary inoculation into ewes.
At least 10% of spontaneous chromosomal antibiotic resistant mutants of bacteria express a strain-dependent graded reduction of virulence; this correlates linearly with a prolonged generation time. Occasionally, these mutants are temperature sensitive or/and auxotrophe. The work described in this paper provides evidence that in such strains the resistance and the accompanying markers exist only as a functional genetic unit. In a series of transduction experiments with a pathogenic strain of Salmonella typhimurium, it was found that without exception, the resistance and the additional markers were 100% simultaneoulsy transferred. Furthermore, antibiotic-resistant Escherichia coli mutants with prolonged generation time, were isolated from faecal samples; it is thus indicated that, such innocuous mutants occur at any time in the intestine. It is concluded that concerns connecting such mutants to the possibility of resistance dissemination are unfounded; furthermore, even if transfer of resistance occurred, only attenuated strains would be disseminated.
BACKGROUND AND OBJECTIVE: Individualized homeopathy is the most controversial form of this therapy. This review aims to summarize the actual state of clinical efficacy research on individualized homeopathy. METHODS: Electronic databases as well as other sources were searched for possibly relevant studies. Randomized or quasirandomized controlled clinical trials comparing an individualized homeopathic treatment strategy with placebo, no treatment, or another treatment were eligible. Information on patients, methods, interventions, outcomes, and results was extracted in a standardized manner and quality was assessed using a checklist and two scoring systems. Trials providing sufficient data were pooled in a quantitative meta-analysis. RESULTS: A total of 32 trials (28 placebo-controlled, 2 comparing homeopathy and another treatment, 2 comparing both) involving a total of 1778 patients met the inclusion criteria. The methodological quality of the trials was highly variable. In the 19 placebo-controlled trials providing sufficient data for meta-analysis, individualized homeopathy was significantly more effective than placebo (pooled rate ratio 1.62, 95% confidence interval 1.17 to 2.23), but when the analysis was restricted to the methodologically best trials no significant effect was seen. CONCLUSION: The results of the available randomized trials suggest that individualized homeopathy has an effect over placebo. The evidence, however, is not convincing because of methodological shortcomings and inconsistencies. Future research should focus on replication of existing promising studies. New randomized studies should be preceded by pilot studies.
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BACKGROUND: Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo. METHODS: We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, "remedy", population, and outcomes. FINDINGS: The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05). INTERPRETATION: The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.
A scientific evaluation of complementary medical practices commonly used in healthcare is urgently required. Although randomized clinical trials are the primary tool for such an evaluation, for a number of conceptual and pragmatic reasons, they should not be the only tool. The authors propose systematic clinical auditing as a concept to (1) provide information on the "epidemiology" of complementary medical practices, (2) make the processes used in the daily practice of these complementary methods clearly intelligible, and (3) give a preliminary estimation of outcomes. Systematic clinical auditing uses mainly observational studies of large samples of patients. A pilot study was conducted to investigate the feasibility of using a systematic clinical audit in a hospital for traditional Chinese medicine in Germany. All 1597 patients admitted between February 1, 1992, and August 31, 1993, were included in the study. Patients' characteristics, diagnoses, and preventive and therapeutic interventions were recorded, and patients were asked to rate the intensity of their main complaints (on scale of 1 to 10) at admission; at discharge; and at 2, 6, and 12 months after admission. About two thirds of all patients had chronic pain complaints; the most common diagnosis was migraine (n = 244). Nearly all patients received acupuncture and Chinese herbal therapy; 61% received tuina massages, and 16% received qigong. The mean intensity of main complaints was 7.0 (2.0, SD) at admission, 4.6 (2.4) at discharge, and 5.5 (2.7) 12 months after admission. In the authors' opinion, systematic clinical auditing is a valuable tool for collecting basic information on structural characteristics, processes, and outcomes in complementary medicine and for determining representative and relevant questions for future randomized clinical trials.